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Insulated Surgical Electrode

by Springfield Surgical Instruments

510(k) K942499

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK942499 Date1 Jul 1994ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GEI
Device Class
Class II
Regulation
21 CFR Part 878.4400
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Insulated Surgical Electrode is a device used in electrosurgical procedures to cut and coagulate soft tissue with radiofrequency energy. It features a 99.5%-insulated electrode design for precise surgical applications. This device is part of the electrosurgical unit electrode category and is manufactured by Springfield Surgical Instruments.

The Insulated Surgical Electrode is supplied as a single-use device and is intended for use in surgical settings. It is FDA 510(k) cleared with clearance number K942499 and product code GEI. The device is stored according to manufacturer specifications and is not MRI compatible. It was cleared on July 1, 1994, for use in general and plastic surgery procedures.

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See all devices from Springfield Surgical Instruments →

Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Insulated Surgical Electrode used for?

    The Insulated Surgical Electrode is designed for electrosurgical procedures to cut and coagulate soft tissue with radiofrequency energy. Its 99.5%-insulated design allows for precise surgical applications in general and plastic surgery settings.

  • Is the Insulated Surgical Electrode reusable or single-use?

    The Insulated Surgical Electrode is supplied as a single-use device and should not be reused. This design ensures optimal performance and safety during surgical procedures, as specified by the manufacturer.

  • What are the storage requirements for the Insulated Surgical Electrode?

    The device should be stored according to the manufacturer's specifications. While specific storage conditions aren't detailed in the provided information, it's important to follow the manufacturer's guidelines to maintain the device's integrity and functionality.

  • Is the Insulated Surgical Electrode MRI compatible?

    No, the Insulated Surgical Electrode is not MRI compatible. This limitation should be considered when planning surgical procedures that may involve MRI imaging, requiring alternative electrode options in such cases.